Cholesterol Medication Study Self-Scheduler

Qualified participants:

• Must be between 18 and 80 years old.
• Must have a BMI ≥ 23 and < 45 kg/m2 [calculate here].
• Must suspect you have high cholesterol or high LDL cholesterol.
• Willing and able to attend regular in‑clinic visits, possibly weekly at first.
• Able to give written informed consent and follow study instructions.

Answers Must Be NO: 

• Are you currently pregnant or breastfeeding?
• Have you used any PCSK9 inhibitor medications (such as Praluent®, Repatha®, or Leqvio®) within the past year?
• Are you planning to start or change any cholesterol‑lowering medications (like statins, ezetimibe, niacin, fibrates, fish oil, or similar) during the next several months?
• In the last several weeks, do you use recreational drugs such as cocaine, methamphetamines, or non‑prescribed opioids?
• Do you have kidney disease stage 3b- stage 5 or an eGFR <45?
• Are you currently participating in another clinical trial that involves a treatment or intervention?
• Have you ever had a serious allergic reaction to alirocumab (Praluent®) or similar injectable cholesterol medications?
• Have you been told you have moderate to severe kidney disease or significantly reduced kidney function?
• Do you currently have a medical condition that would make it hard to complete regular study visits?
• Are you, or an immediate family member, part of the study staff at the research site?
• Are you a Regeneron employee or someone living in the same household as a Regeneron employee who works on this study?

Answers Must Be YES: 

• Are you willing to use a highly effective form of birth control during the study and for at least 8 weeks after the last dose of study medication? 
• Women of non-childbearing potential must be either;
  • Postmenopausal state is defined as no menses for 12 months without an alternative medical cause. OR
  • Be permanently sterilized via Documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy  
• For individuals with permanent infertility due to an alternate medical cause 
  • If you are currently on lipid-lowering therapy (statin, ezetimibe, niacin, fibrates, icosapent ethyl, omega 3/fish oil), have you been on stable dose for at least 8 weeks? 
  • If you have stopped your lipid-lowering therapy and no longer on it, has it been at least 4 weeks since your last dose? 
  • If you are currently on vitamins with possible effect on lipids (e.g., niacin [as over-the-counter supplement], omega 3/fishoil [as over-the-counter supplement], red yeast rice), have you been on stable dose for at least 4 weeks prior? Note:  New starts or dose escalation are not permitted until the end of the study.​ 
  • Are you willing to not donate sperm or eggs during the study and for 8 weeks after the last dose? 
• For male participants: are you willing to use condoms during sexual activity where pregnancy could occur?
• If you are currently taking any of the following medications, have you been on a stable dosefor at least 4 weeks? Selective estrogen receptor modulators (e.g., tamoxifen, raloxifene)​, Anabolic steroids (e.g., androgens, danazol)​, Glucocorticoids (oral)​, Protease inhibitors (e.g., ritonavir, lopinavir, darunavir)​, Retinoids (e.g., isotretinoin)​, Growth hormone​, Calcineurin inhibitors (e.g., tacrolimus, cyclosporine)​, mTOR inhibitors (e.g., sirolimus, everolimus) 
• If you are currently on treatment for hypothyroidism, have you been on a stable dose of levothyroxine for at least 8 weeks? Note: Adjustments are permissible during the study if indicated at screening visit 

PLEASE NOTE: Please confirm your eligibility before your appointment by calling 210-714-0067

• If you do not see an available appointment, please call 210-714-0067 for availability.

• Transportation may be available. Call 210-714-0067. Compensation up to $2,462 may be available for time and travel.

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